Safety of a Contraceptive Copper Vaginal Ring

N/ANot Yet RecruitingNCT07666997

Elle, MD Biotechnologies Inc.8 enrolled

Overview

Many birth control options today come with unwanted side effects or risks. Hormonal methods can affect both mental and physical health, while devices like copper IUDs carry risks such as uterine perforation or infection. This study is testing a new option: a copper vaginal ring (CVR) - a non-hormonal, non-invasive contraceptive that can be self-inserted, similar to a other vaginal rings like NuvaRing or Annovera. The main goal of this study is to assess whether the copper vaginal ring is safe to use. Researchers will also look at how comfortable and easy it is to use, whether participants follow the instructions, and how much copper accumulates in cervical mucus and vaginal fluid during use. The study will enroll 8 women of childbearing age. Participants wear the ring continuously for 28 days, inserting it on Day 5 of their menstrual cycle. Over the course of the study, participants will attend 8 in-person clinic visits, which include pelvic exams, vaginal swabs, blood draws, and cervical mucus collection. On the day the ring is removed (Day 28), small tissue samples (biopsies) are taken from the vagina and uterine lining. At the end of the study, participants will complete a short survey about their experience with the ring.

Current contraceptive options have a variety of unwanted risks and side effects. Hormonal options are among the most effective and widely used contraceptives but come with a long list of potential risks. Hormonal birth control can lead to impaired glucose metabolism, reduced bone mineral density, headaches, poor libido, irregular periods, depression and suicide. High efficacy contraceptive options (such as intrauterine devices; IUDs) have their own drawbacks. While IUDs are generally safe, they pose more serious risks such as infection, perforation of the uterine wall during insertion, or the IUD being expelled from the uterus. They also involve a medical procedure to insert and remove. Therefore, many women prefer less invasive options when considering birth control methods. There is a gap in the current options for non-hormonal birth control methods that are minimally invasive and pose few serious risks. The copper vaginal ring (CVR) is a novel contraceptive device for the prevention of pregnancy. The copper ring utilizes a non-hormonal design and is anticipated to have fewer side effects than the copper IUD due to its placement further from the uterus, its shorter duration of use, and the fact that insertion does not require an invasive procedure. The primary objective of this study is to determine the safety of a copper-containing vaginal ring in women. The secondary objectives of this study are to assess the fit, tolerability and adherence to copper vaginal ring instructions for use, and to determine what concentration of copper accumulates in the cervical mucus and vaginal fluid during use of the ring. The study will enroll 8 women of childbearing age. All of the participants will use the study device for a duration of 28 days. Participants will come back to the clinic on day 5 of their cycle for a baseline assessment and to insert the ring. After 28 days of continuous use, all the participants will have their vaginal rings removed. The study involves undergoing pelvic examinations, collection of vaginal fluid using vaginal swabs, collection of blood samples and cervical mucus before the trial starts (baseline), followed by pelvic exams, vaginal swabs, cervical mucus and blood collection occurring again at each of the 8 in-person visits. Visits occur at baseline, and on days 1, 2, 7, 14, 21, 28 and 35. On day 28, immediately after removal of the ring, biopsy samples from both the vagina and the endometrium will be taken. At the end of the 28-day cycle, during the removal visit, all the participants will complete a survey with questions about the usability, tolerability, acceptability and adherence to use of the copper vaginal ring.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Biological female * Age \>18 * Premenopausal women * Regular, normal, cyclic menses, with a usual length of 21 to 35 days * Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol Exclusion Criteria: * Use of oral contraceptives, Copper-IUD, hormonal-IUD, another intravaginal contraceptive device, or any other method of female birth control within 3 months prior to study enrollment * Postmenopausal * Biological male * Positive urine pregnancy test at screening visit * Use of hormone therapy; injectable within the past 6 months; implantable within the past 3 months; * Presence of a vaginal/cervical/uterine anomaly or a diagnosed pathology that effects the vaginal cavity and may impair the ability to safely insert/remove a vaginal ring. * The presence of certain conditions of relevance to vaginal ring use, such as cervicitis, vaginitis or bleeding cervical erosion; lichen sclerosis, lichen planus or vaginismus; Papanicolau (PAP) grade III-V cervical smear result; prolapse of uterine cervix, cystocele and/or rectocele; severe or chronic constipation, dyspareunia or other coital problems; . * History or current diagnosis of any of the following: * gynecological cancer * fibroids * polycystic ovary syndrome * Past exposure to radiation therapy to the pelvis, or planned radiation therapy to the pelvis during the study; * Current diagnosis of a sexually transmitted disease; * Wilson's Disease; * Known allergy to metal or silicone * Had an abortion or breastfeeding within 2 months before the start of the trial; * Presence of a significant medical condition or health concern that, in the opinion of the investigator, may impact the patient's safety or the study's outcomes; * A condition that, in the opinion of the investigator, precludes the patient from being able to provide informed consent; * Inability or unwillingness to refrain from using a tampon/menstrual cup for the duration of the study. * Known inability to tolerate products/devices in the vagina (i.e., tampons, menstrual cups, vaginal rings, etc.)

Outcomes

Primary Outcomes

Adverse Events [Safety]

Safety of the CVR will be assessed by recording all adverse events (AEs). AEs will be recorded and categorized based on their relationship to the study device and their expectedness. Serious Adverse Events (SAEs) and Unanticipated Adverse Device Affects (UADEs) will be tracked and represent the key metrics for an "unsafe" outcome with device use. These outcomes will be obtained by patient reports.

Time frame: From enrollment to the end of treatment on Day 35

Secondary Outcomes

Acceptability/Tolerability of the Device

Acceptability and tolerability of device use, including ease of insertion, aspects liked most and least about the device, and comfort by both partners during intercourse with the device inserted will be assessed using a validated Vaginal Ring tolerability questionnaire. The questionnaire consists of 20 questions and all answers are scored on a 5-point likert scale. Higher scores equate to higher acceptability/tolerability of the ring.

Time frame: Assessed on Day 28 upon removal of the device

Device Malfunctions and Complications [Safety]

Device malfunctions include problems with the ring's structural integrity, copper component dimensional/tolerance failures, material degradation, or problems with the packaging. Device-related complications refer to problems that are mechanical or physical in nature (such as expulsion), local tissue effects, copper-specific problems, partner/coitus-related complications, or infection attributable to the ring. These outcomes will be obtained by the principle investigator during physical exams and by patient reports.